China Kallidinogenase na Deebio ga iri-iri na zuciya da jijiyoyin jini da kuma Cerebovascular cuta factory da kuma masana'antun |Deebiotech

Kallidinogenase na Deebio don nau'ikan cututtukan zuciya da jijiyoyin jini

CAS NO.:9001-01-8

HS CODE:3507.9090.90

Sabis na Fayil:Sinanci-GMP, DMF

Matsayin Pharmacopoeia:JP/CP

Aika mana imel samfurin kyauta

Cikakken Bayani

Tags samfurin

Daki-daki

1. Halaye: Fari ko kusan fari foda, mara wari.

2. Tushen hakar: Porcine pancreas.

3. Tsari: Ana fitar da Kallidinogenase daga lafiyayyen naman alade.

4. Alamu da amfani: Ana iya amfani da wannan samfur don nau'ikan cututtukan zuciya da jijiyoyin jini, kamar cututtukan zuciya na jijiyoyin jini, jijiyoyin bugun jini, thrombosis na cerebral, rikicewar samar da jini na retinal da cututtukan jijiyoyin bugun jini.Samun ingantaccen sakamako na warkewa akan binciken da aka yi kwanan nan don rigakafin ƙwayar cuta ta farko na ciwon sukari microangiopathy da ciwon sukari nephropathy, na iya rage fitowar albumin.Bayanan asibiti a gida da waje sun nuna cewa yana iya ƙara yawan aikin maniyyi da kuma samar da yawa, kuma yana da wani tasiri na warkewa a cikin maganin wasu haifuwa na maza.

Me yasa mu?

· An yi shi a cikin taron GMP

· 27 shekaru na nazarin halittu enzyme R&D tarihi

Ana iya gano albarkatun kasa

· Bi daidaitattun abokin ciniki

· Fitarwa zuwa ƙasashe da yankuna sama da 30

Yana da ikon sarrafa tsarin inganci kamar US FDA, Japan PMDA, Koriya ta Kudu MFDS, da dai sauransu.

Ƙayyadaddun bayanai

Kayan Gwaji		Ƙayyadaddun Kamfanin
Kayan Gwaji		CP	JP
Halaye		Fari ko kusan fari foda, mara wari	Fari zuwa ƴan launin ruwan hoda, mara wari ko yana da suma
Ganewa		R (ƙididdigar hydrolysis): 0.12～0.17	R (ƙididdigar hydrolysis): 0.12～0.16
Ganewa		Liquid Chromatography: Daidaita	Ina: ≤ 0.2
Gwaji	pH	5.5～7.5(300 raka'a/ml)	5.5～7.5(1 g/300ml)
	Bayyanar bayani	Share(2mg/ml)	————
	Kiba	≤ 5.0mg/g	≤ 1.0mg/g
	Kininase	————	R Darajar:0.8
	Abu mai kama da Trypsin	————	T Darajar:≤ 0.05
	Protease	A₂₈₀≤ 0.2	A₂₈₀≤ 0.2
	Asarar bushewa	≤ 5.0% (60 ℃ Dry in Vacuum, 4h)	≤ 2.0% (60 ℃ Dry in Vacuum, 4h)
	Ragowa akan kunnawa	≤ 3.0%	≤ 3.0%
	Ayyukan sakin Kinin	————	≥ 500ng bradykinin daidai / min / raka'a ta ɗaya
	Tsafta	≥ 75% (na baka)	————
	Tsafta	≥ 90% (don allura)	————
	Bacterial endotoxin	≤ 2.5 EU/raka'a (don allura)	————
Assay	Enzyme aiki	————	≥ 25 raka'a/mg
	takamaiman ayyuka	≥ 300 naúrar / MG protein (na baka)	≥ 100 raka'a/mg sunadaran
	takamaiman ayyuka	≥ 600 naúrar / MG protein (don allura)	≥ 100 raka'a/mg sunadaran
Najasa Na Ƙanƙara	TAMC	≤ 1000cfu/g (na baka)	≤ 1000cfu/g
	TAMC	≤ 100cfu/g (don allura)	≤ 1000cfu/g
	Farashin TYMC	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Ya dace	Ya dace
	Salmonella	Ya dace	Ya dace